Ovarian Reserve Following Bilateral Salpingectomy Versus Tubal Ligation During Cesarean Section
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Wolfson Medical Center
- Enrollment
- 45
- Primary Endpoint
- Change from baseline in Anti Mullerian hormone (AMH) levels ng/mL at 8 weeks
Study Overview
Brief Summary
The aforementioned study was designed to evaluate short term ovarian reserve as assessed by anti-Mullerian hormone(AMH) levels following bilateral salpingectomy versus tubal ligation, as part of cesarean sections performed in women requesting future sterilization. The investigators aim to recruit 3 groups of 15 women undergoing elective cesarean section at the investigators' institution, 2 of which request sterilization (allocated to tubal ligation or bilateral salpingectomy) and one undergoing solely cesarean section. The groups will have blood drawn for AMH prior to the procedure and at a post-operation visit 8 weeks following. This is preformed in light of validated data offering better sterilization and possible diminished future risk of ovarian cancer with salpingectomy. Also, is has been proved to be just as safe as tubal ligation. This will be performed as a randomized controlled trial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women undergoing elective cesrean section at the investigators' institution, requesting sterilization, willing to have blood withdrawn for AMH levels prior to surgery, willing to participate in 8 weeks post-operation follow up with blood withdrawn
Exclusion Criteria
- •Non-elective cesarean section, non willing to have blood withdrawn or participate in follow up, prior salpingectomy, prior premature ovarian failure/egg donation
Outcomes
Primary Outcomes
Change from baseline in Anti Mullerian hormone (AMH) levels ng/mL at 8 weeks
Time Frame: Baseline and 8 weeks following surgery
AMH levels
Secondary Outcomes
No secondary outcomes reported
Investigators
Hadas Ganer Herman
Dr.
Wolfson Medical Center